Skip to content
Please enter a keyword to search

  • IEC 61010-2-040:2015

    View superseded by
    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
    View superseded by

    Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Superseded date:  31-12-2021

    Language(s):  English - French

    Published date:  07-07-2015

    Publisher:  International Electrotechnical Committee

    Add To Cart

    Table of Contents - (Show below) - (Hide below)

    FOREWORD
    1 Scope and object
    2 Normative references
    3 Terms and definitions
    4 Tests
    5 Marking and documentation
    6 Protection against electric shock
    7 Protection against mechanical HAZARDS and
       against HAZARDS related to mechanical functions
    8 Mechanical resistance to shock and impact
    9 Protection against the spread of fire
    10 Equipment temperature limits and resistance
       to heat
    11 Protection against HAZARDS from fluids
    12 Protection against radiation, including laser sources,
       and against sonic and ultrasonic pressure
    13 Protection against liberated gases, substances,
       explosion and implosion
    14 Components
    15 Protection by interlocks
    16 HAZARDS resulting from application
    17 RISK assessment
    Annexes
    Annex G (informative) - Leakage and rupture from fluids
            under pressure
    Annex L (informative) - Index of defined terms
    Bibliography

    Abstract - (Show below) - (Hide below)

    IEC 61010-2-040:2015 specifies safety requirements for electrical equipment intended for sterilization, washing, and disinfection of medical materials in the medical, veterinary, pharmaceutical and laboratory fields, when used under the environmental conditions of 1.4. It has the status of a group safety publication, as specified in IEC Guide 104. This second edition cancels and replaces the first edition published in 2005. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition:
    a) A new clause (4.3.2.101) has been added for non-electrical supplies and services.
    b) Additional requirements for marking and documentation (Clause 5) have been added.
    c) Additional requirements for protection against mechanical hazards (Clause 7) have been included.
    d) Additional requirements for protection against radiation, including laser sources, and against sonic and ultrasonic pressure (Clause 12) have been included.

    General Product Information - (Show below) - (Hide below)

    Committee TC 66
    Development Note Supersedes IEC 61010-2-041, IEC 61010-2-042, IEC 61010-2-043 and IEC 61010-2-045. (04/2005) Stability Date: 2017. (07/2015)
    Document Type Standard
    Publisher International Electrotechnical Committee
    Status Superseded
    Superseded By
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    DIN EN ISO 25424:2011-09 STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    CSA Z17665-2:09 (R2019) Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 (Adopted ISO/TS 17665-2:2009, first edition, 2009-01-15)
    DIN EN ISO 11135-1:2007-08 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    DIN EN ISO 15883-7 E : 2016 WASHER-DISINFECTORS - PART 7: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR NON-INVASIVE, NON-CRITICAL THERMOLABILE MEDICAL DEVICES AND HEALTHCARE EQUIPMENT (ISO 15883-7:2016)
    I.S. EN 15424:2007 STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    PD ISO/TS 17665-3:2013 Sterilization of health care products. Moist heat Guidance on the designation of a medical device to a product family and processing category for steam sterilization
    04/30081258 DC : DRAFT MARCH 2004 BS EN ISO 11737-1 - STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 1 - DETERMINATION OF A POPULATION OF MICRO ORGANISMS ON PRODUCTS
    DIN EN ISO 11135:2014-10 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11135:2014)
    PREN 285 : DRAFT 2013 STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
    AAMI ISO 17665-1 : 2006 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    CSA Z11135-1 :2009 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    CSA Z11135 : 2015 STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    CSA ISO 14937 : 2011 STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    CSA Z17665-1:09 (R2019) Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (Adopted ISO 17665-1:2006, first edition, 2006-08-15, with Canadian deviations)
    ANSI/AAMI/ISO 11135:2014 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    CSA Z17665-1 : 2009 : FR STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
    DIN EN 1422:2014-08 STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
    ISO 11135-1:2007 Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
    BS EN 15424:2007 Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices
    NF EN 285 : 2016 STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
    DIN EN ISO 15883-4:2009-09 WASHER-DISINFECTORS - PART 4: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR THERMOLABILE ENDOSCOPES
    DIN EN 15424:2007-08 STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    PREN 1422 : DRAFT 2011 STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
    DIN EN ISO 15883-4:2016-07 (Draft) WASHER-DISINFECTORS - PART 4: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR THERMOLABILE ENDOSCOPES
    12/30248648 DC : DRAFT AUG 2012 BS EN 16442 - CONTROLLED ENVIRONMENT STORAGE CABINET FOR DISINFECTED THERMOLABILE ENDOSCOPES
    AAMI ISO TIR 17665-3:2014 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - GUIDANCE ON THE DESIGNATION OF A MEDICAL PRODUCT TO A PRODUCT FAMILY AND PROCESSING CATEGORY FOR STEAM STERILIZATION
    12/30262894 DC : 0 BS EN 14180 - STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING
    I.S. EN ISO 17665-1:2006 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    BS EN ISO 15883-7:2016 Washer-disinfectors Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment
    11/30252448 DC : 0 BS EN 1422 - STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
    I.S. EN ISO 11135:2014 STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11135:2014)
    12/30252545 DC : 0 BS ISO 15883-1:2006/AMD - WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS
    11/30244091 DC : 0 BS EN ISO 11135 - STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    CAN/CSA-ISO 15883-7:17 Washer-disinfectors — Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment (Adopted ISO 15883-7:2016, first edition, 2016-02-01)
    UNE-EN ISO 11135:2015 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)
    04/30048205 DC : DRAFT JUL 2004 BS EN ISO 17665 - STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    ANSI/AAMI ST55:2016 TABLE-TOP STEAM STERILIZERS
    BS EN ISO 11135:2014 Sterilization of health-care products. Ethylene oxide. Requirements for the development, validation and routine control of a sterilization process for medical devices
    UNI CEN ISO/TS 17665-2 : 2009 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1
    CSA Z17665-1 : 2009 : R2014 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    I.S. EN ISO 25424:2011 STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    ANSI/AAMI ST8:2013(R2018) HOSPITAL STEAM STERILIZERS
    ANSI/AAMI ST15883-1:2009(R2014) &A1:2014&A2:2012 WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS
    AAMI ST15883-1 : 2009 : INC : AMD 1 : 2014 : R201400 WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS
    EN ISO 14937:2009 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)
    DIN EN ISO 17665-1:2006-11 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)
    ISO 25424:2009 Sterilization of medical devices Low temperature steam and formaldehyde Requirements for development, validation and routine control of a sterilization process for medical devices
    I.S. EN ISO 14937:2009 STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    I.S. EN 1422:2014 STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
    DIN EN 14180:2003-10 STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING
    I.S. EN 14180:2014 STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING
    DIN EN 1422:1997-11 STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
    ANSI/AAMI/ISO 20857:2010(R2015) STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    I.S. EN 285:2015 STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
    BS EN 60335-2-58 : 2005 HOUSEHOLD AND SIMILAR ELECTRICAL APPLIANCES - SAFETY - PART 2-58: PARTICULAR REQUIREMENTS FOR COMMERCIAL ELECTRIC DISHWASHING MACHINES
    UNI EN ISO 25424 : 2011 STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    09/30196750 DC : DRAFT MAY 2009 BS EN ISO 15883-6 - WASHER-DISINFECTORS - PART 6: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR NONINVASIVE, NON-CRITICAL MEDICAL DEVICES AND HEALTHCARE EQUIPMENT
    13/30278676 DC : 0 BS EN 285 - STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
    BS EN ISO 15883-4:2009 Washer-disinfectors Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
    17/30338806 DC : 0 BS EN ISO 25424 - STERILIZATION OF HEALTH CARE PRODUCTS - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    EN ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)
    CSA Z11135-1 : 2009 : R2014 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    CSA Z15883-4 : 2009 Washer-disinfectors — Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2008, IDT)
    CSA ISO 14937 : 2011 : R2016 STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    ISO 15883-4:2008 Washer-disinfectors Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
    CSA Z17665-2:09 (R2019) Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1 (ISO/TS 17665-2:2009, IDT)
    AAMI ISO 14937:2009 STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    ANSI/AAMI ISO 17665-1:2006(R2013) STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    EN 13060:2014 Small steam sterilizers
    AAMI ISO 11135-1 : 2007 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    I.S. EN ISO 15883-7:2016 WASHER-DISINFECTORS - PART 7: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR NON-INVASIVE, NON-CRITICAL THERMOLABILE MEDICAL DEVICES AND HEALTHCARE EQUIPMENT (ISO 15883-7:2016)
    BS EN ISO 15883-6:2015 Washer-disinfectors Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment
    DIN EN ISO 15883-6:2016-04 Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment (ISO 15883-6:2011)
    AAMI ST15883-1 : 2009 WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS
    ISO/TS 17665-3:2013 Sterilization of health care products — Moist heat — Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization
    IEC 60335-2-58 REDLINE : 4ED 2017 HOUSEHOLD AND SIMILAR ELECTRICAL APPLIANCES - SAFETY - PART 2-58: PARTICULAR REQUIREMENTS FOR COMMERCIAL ELECTRIC DISHWASHING MACHINES
    IEC 60335-2-58:2017 Household and similar electrical appliances - Safety - Part 2-58: Particular requirements for commercial electric dishwashing machines
    DIN EN 13060:2015-03 SMALL STEAM STERILIZERS
    DIN EN 285:2016-05 Sterilization - Steam sterilizers - Large sterilizers
    ISO 15883-1:2006 Washer-disinfectors Part 1: General requirements, terms and definitions and tests
    IEC 60335-2-58:2017 RLV Household and similar electrical appliances - Safety - Part 2-58: Particular requirements for commercial electric dishwashing machines
    I.S. EN ISO 15883-1:2009 WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS (ISO 15883-1:2006)
    UNI EN ISO 14937 : 2009 STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    UNI EN 14180 : 2014 STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING
    UNI EN 1422 : 2014 STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS
    DIN EN ISO 20857 E : 2013 STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 20857:2010)
    PREN 17180 : DRAFT 2017 STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE VAPORIZED HYDROGEN PEROXIDE STERILIZERS - REQUIREMENTS AND TESTING
    BS EN ISO 25424:2011 Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices
    UNI EN ISO 11135 : 2014 STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    ISO 15883-7:2016 Washer-disinfectors — Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment
    AAMI ISO TIR 17665-2 : 2009 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ANSI/AAMI/ISO 17665-1
    I.S. EN ISO 11135-1:2007 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    16/30288024 DC : 0 BS EN ISO 15883-4 - WASHER-DISINFECTORS - PART 4: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR THERMOLABILE ENDOSCOPES
    UNE-EN ISO 20857:2013 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010)
    I.S. EN ISO 20857:2013 STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 20857:2010)
    07/30164697 DC : 0 ISO 20857 - STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF AN INDUSTRIAL STERILIZATION PROCESS FOR MEDICAL DEVICES
    AAMI ST15883-3 : 2012 WASHER-DISINFECTORS - PART 3: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR HUMAN WASTE CONTAINERS
    UNI EN ISO 20857 : 2013 STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    CSA Z11135-1 : 2009 : FR STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    DIN EN ISO 20857:2013-08 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010)
    I.S. EN ISO 15883-4:2009 WASHER-DISINFECTORS - PART 4: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR THERMOLABILE ENDOSCOPES
    AAMI/ISO TIR17665-2:2009(R2016) STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ANSI/AAMI/ISO 17665-1
    UNI EN ISO 15883-4 : 2009 WASHER-DISINFECTORS - PART 4: REQUIREMENTS AND TESTS FOR WASHER- DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR THERMOLABILE ENDOSCOPES
    UNE-EN ISO 15883-6:2015 Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment (ISO 15883-6:2011)
    PREN ISO 15883-6 : DRAFT 2009 WASHER-DISINFECTORS - PART 6: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR NONINVASIVE, NON-CRITICAL MEDICAL DEVICES AND HEALTHCARE EQUIPMENT
    EN ISO 15883-4:2009 Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2008)
    I.S. EN 60335-2-58:2005 HOUSEHOLD AND SIMILAR ELECTRICAL APPLIANCES - SAFETY - PART 2-58: PARTICULAR REQUIREMENTS FOR COMMERCIAL ELECTRIC DISHWASHING MACHINES
    UNE-EN ISO 15883-1:2009 Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006)
    DIN EN 14180:2014-09 STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING
    ISO 14937:2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
    BS EN ISO 17665-1:2006 Sterilization of health care products. Moist heat Requirements for the development, validation and routine control of a sterilization process for medical devices
    BS EN ISO 14937:2009 Sterilization of health care products. General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
    ANSI/AAMI ST15883-2:2013(R2015) (ISO 15883-2:2006 MOD) WASHER-DISINFECTORS - PART 2: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR SURGICAL INSTRUMENTS, ANESTHETIC EQUIPMENT, BOWLS, DISHES, RECEIVERS, UTENSILS, GLASSWARE, ETC.
    ISO 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
    BS EN 13060 : 2014 SMALL STEAM STERILIZERS
    BS EN 285:2015 Sterilization. Steam sterilizers. Large sterilizers
    UNE-EN ISO 14937:2010 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)
    BS EN 14180:2014 Sterilizers for medical purposes. Low temperature steam and formaldehyde sterilizers. Requirements and testing
    BS EN ISO 15883-1 : 2009 WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS (ISO 15883-1:2006)
    EN ISO 15883-7:2016 Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment (ISO 15883-7:2016)
    EN 15424:2007 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
    EN ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)
    EN ISO 25424:2011 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2009)
    EN 1422:2014 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
    EN ISO 15883-6:2015 Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment (ISO 15883-6:2011)
    EN ISO 20857:2013 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010)
    EN 14180:2014 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
    EN ISO 17665-1 : 2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)
    BS EN ISO 20857:2013 Sterilization of health care products. Dry heat. Requirements for the development, validation and routine control of a sterilization process for medical devices
    ANSI/AAMI/ISO 14937:2009(R2013) STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    DIN EN ISO 15883-7:2016-10 WASHER-DISINFECTORS - PART 7: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR NON-INVASIVE, NON-CRITICAL THERMOLABILE MEDICAL DEVICES AND HEALTHCARE EQUIPMENT (ISO 15883-7:2016)
    PREN ISO 11135 : DRAFT 2011 STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO/DIS 11135:2011)
    DD CEN ISO/TS 17665-2:2009 Sterilization of health care products. Moist heat Guidance on the application of ISO 17665-1
    CAN/CSA-ISO 15883-6:17 Washer-disinfectors — Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive , non-critical medical devices and healthcare equipment (Adopted ISO 15883-6:2011, first edition, 2011-04-15)
    CSA Z17665-2 : 2009 : R2014 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1
    S.R. CEN ISO/TS 17665-2:2009 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1
    I.S. EN 13060:2014 SMALL STEAM STERILIZERS
    AAMI ISO 20857 : 2010 STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    AAMI/ISO TIR17665-3:2014(R2016) STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - GUIDANCE ON THE DESIGNATION OF A MEDICAL PRODUCT TO A PRODUCT FAMILY AND PROCESSING CATEGORY FOR STEAM STERILIZATION
    UNE-EN ISO 15883-7:2016 Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment (ISO 15883-7:2016)
    AAMI ST15883-2 : 2013 WASHER-DISINFECTORS - PART 2: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR SURGICAL INSTRUMENTS, ANESTHETIC EQUIPMENT, BOWLS, DISHES, RECEIVERS, UTENSILS, GLASSWARE, ETC.
    CSA Z15883-4 : 2009 : R2014 WASHER-DISINFECTORS - PART 4: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR THERMOLABILE ENDOSCOPES
    UNE-EN 13060:2015 Small steam sterilizers
    UNE-EN ISO 25424:2011 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2009)
    I.S. EN ISO 15883-6:2015 WASHER-DISINFECTORS - PART 6: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR NONINVASIVE, NON-CRITICAL MEDICAL DEVICES AND HEALTHCARE EQUIPMENT (ISO 15883-6:2011)
    ISO 11135:2014 Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
    DIN EN ISO 15883-1:2014-10 WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS (ISO 15883-1:2006 + AMD 1:2014)
    UNE-EN 285:2016 Sterilization - Steam sterilizers - Large sterilizers
    BS EN 1422:2014 Sterilizers for medical purposes. Ethylene oxide sterilizers. Requirements and test methods
    BS EN ISO 11135-1:2007 Sterilization of health care products. Ethylene oxide Requirements for development, validation and routine control of a sterilization process for medical devices
    ISO/TS 17665-2:2009 Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1
    ISO 15883-6:2011 Washer-disinfectors — Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment
    ISO 20857:2010 Sterilization of health care products Dry heat Requirements for the development, validation and routine control of a sterilization process for medical devices
    EN ISO 15883-1:2009/A1:2014 WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS (ISO 15883-1:2006/AMD 1:2014)
    DIN EN ISO 14937:2010-03 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)
    CEN ISO/TS 17665-2:2009 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 (ISO/TS 17665-2:2009)
    EN 60335-2-58:2005/A12:2016 HOUSEHOLD AND SIMILAR ELECTRICAL APPLIANCES - SAFETY - PART 2-58: PARTICULAR REQUIREMENTS FOR COMMERCIAL ELECTRIC DISHWASHING MACHINES (IEC 60335-2-58:2002, MODIFIED)

    Standards Referencing This Book - (Show below) - (Hide below)

    IEC 61672-2:2013+AMD1:2017 CSV Electroacoustics - Sound level meters - Part 2: Pattern evaluation tests
    IEC 60335-2-11:2008+AMD1:2012+AMD2:2015 CSV Household and similar electrical appliances - Safety - Part 2-11:Particular requirements for tumble dryers
    ISO 2903:2016 ISO metric trapezoidal screw threads — Tolerances
    ISO 15223-2:2010 Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation
    ISO 2904:1977 ISO metric trapezoidal screw threads — Basic dimensions
    ISO 4126-1:2013 Safety devices for protection against excessive pressure — Part 1: Safety valves
    IEC 60335-2-7 : 7.2 HOUSEHOLD AND SIMILAR ELECTRICAL APPLIANCES - SAFETY - PART 2-7: PARTICULAR REQUIREMENTS FOR WASHING MACHINES
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    ISO 3585:1998 Borosilicate glass 3.3 Properties
    EN 1837:1999+A1:2009 Safety of machinery - Integral lighting of machines
    IEC TR 62471-2:2009 Photobiological safety of lamps and lamp systems - Part 2: Guidance on manufacturing requirements relating to non-laser optical radiation safety
    IEC 60335-2-7:2008+AMD1:2011+AMD2:2016 CSV Household and similar electrical appliances - Safety - Part 2-7:Particular requirements for washing machines
    IEC 60825-1:2014 Safety of laser products - Part 1: Equipment classification and requirements
    ISO 12100:2010 Safety of machinery — General principles for design — Risk assessment and risk reduction
    IEC 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
    ISO 4126-2:2003 Safety devices for protection against excessive pressure Part 2: Bursting disc safety devices
    ISO 2902:2016 ISO metric trapezoidal screw threads General plan
    ISO 13849-2:2012 Safety of machinery — Safety-related parts of control systems — Part 2: Validation
    IEC 60335-2-5:2012 Household and similar electrical appliances - Safety - Part 2-5: Particular requirements for dishwashers
    IEC 62471:2006 Photobiological safety of lamps and lamp systems
    EN 14222:2003 Stainless steel shell boilers
    IEC 61010-2-010:2014 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-010: Particular requirements for laboratory equipment for the heating of materials
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    IEC 62061:2005+AMD1:2012+AMD2:2015 CSV Safety of machinery - Functional safety of safety-related electrical, electronic and programmable electronic control systems
    IEC 61770:2008+AMD1:2015 CSV Electric appliances connected to the water mains - Avoidance ofbacksiphonage and failure of hose-sets
    ISO 2901:2016 ISO metric trapezoidal screw threads Basic and design profiles
    IEC 60335-2-58:2002+AMD1:2008+AMD2:2015 CSV Household and similar electrical appliances - Safety - Part 2-58: Particular requirements for commercial electric dishwashing machines
    View more information

    • Access your standards online with a subscription

      Features

      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective